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RU2015114784A - HYALURONIDASE STABILIZER AND LIQUID COMPOSITION CONTAINING HYALURONIDASE - Google Patents

HYALURONIDASE STABILIZER AND LIQUID COMPOSITION CONTAINING HYALURONIDASE Download PDF

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RU2015114784A
RU2015114784A RU2015114784A RU2015114784A RU2015114784A RU 2015114784 A RU2015114784 A RU 2015114784A RU 2015114784 A RU2015114784 A RU 2015114784A RU 2015114784 A RU2015114784 A RU 2015114784A RU 2015114784 A RU2015114784 A RU 2015114784A
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hyaluronidase
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buffer
composition
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RU2647835C2 (en
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Коо ВОО
Ха-На КИМ
Йон-Чжун БАИК
Сун-Хее ЛЕЕ
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БиЭмАй КОРЕА КО., ЛТД
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Abstract

1. Жидкая композиция гиалуронидазы, содержащаягиалуронидазу, имеющую чистоту 95% или более и специфическую активность 70000 МЕ/мг или более, и стабилизатор гиалуронидазы, содержащий буферный агент для обеспечения рН от 4,0 до 6,0; от 0,001 до 0,5 об./об. % неионного поверхностно-активного вещества и от 0,1 до 5 мМ хелатообразующего агента или MgCl.2. Жидкая композиция гиалуронидазы по п. 1, представляющая собой инъецируемую композицию.3. Жидкая композиция гиалуронидазы по п. 1, обладающая стабильностью для поддержания активности гиалуронидазы вплоть до 90% или более по отношению к исходной ферментативной активности, принимаемой за 100, при температурных условиях от 2 до 8°C.4. Жидкая композиция гиалуронидазы по п. 1, где гиалуронидаза представляет собой активный компонент композиции.5. Жидкая композиция гиалуронидазы по п. 4, где хелатообразующий агент представляет собой EDTA (этилендиаминтетрауксусная кислота).6. Жидкая композиция гиалуронидазы по п. 4, где неионное поверхностно-активное вещество выбрано из группы, состоящей из сложного эфира полиоксиэтиленсорбита и жирной кислоты и Triton Х-100.7. Жидкая композиция гиалуронидазы по п. 6, где неионное поверхностно-активное вещество выбрано из группы, состоящей из полисорбата 20, полисорбата 80 и Triton Х-100.8. Жидкая композиция гиалуронидазы по п. 4, где буферный агент выбран из группы, состоящей из сукцинатного буфера, ацетатного буфера, фосфатного буфера, цитратного буфера, малонатного буфера, буфера на основе 2-(N-морфолино)этансульфоновой кислоты (MES), буфера Tris и глицинового буфера.9. Жидкая композиция гиалуронидазы по п. 1, где гиалуронидаза представляет собой рекомбинантную гиалуронидазу, полученную путем трансдукции гена гиалуронидазы млекопитающих в1. A liquid hyaluronidase composition containing hyaluronidase having a purity of 95% or more and a specific activity of 70,000 IU / mg or more, and a hyaluronidase stabilizer containing a buffering agent to provide a pH of from 4.0 to 6.0; from 0.001 to 0.5 vol./about. % non-ionic surfactant and from 0.1 to 5 mm chelating agent or MgCl. 2. The liquid hyaluronidase composition according to claim 1, which is an injectable composition. The liquid hyaluronidase composition according to claim 1, which is stable for maintaining hyaluronidase activity up to 90% or more with respect to the initial enzymatic activity, taken as 100, under temperature conditions from 2 to 8 ° C. The hyaluronidase liquid composition according to claim 1, wherein the hyaluronidase is an active component of the composition. The hyaluronidase liquid composition according to claim 4, wherein the chelating agent is EDTA (ethylenediaminetetraacetic acid). The hyaluronidase liquid composition according to claim 4, wherein the nonionic surfactant is selected from the group consisting of polyoxyethylene sorbitan fatty acid ester and Triton X-100.7. The liquid hyaluronidase composition of claim 6, wherein the nonionic surfactant is selected from the group consisting of polysorbate 20, polysorbate 80, and Triton X-100.8. The hyaluronidase liquid composition according to claim 4, wherein the buffering agent is selected from the group consisting of succinate buffer, acetate buffer, phosphate buffer, citrate buffer, malonate buffer, 2- (N-morpholino) ethanesulfonic acid (MES) buffer, Tris buffer and glycine buffer. 9. The liquid hyaluronidase composition of claim 1, wherein the hyaluronidase is a recombinant hyaluronidase obtained by transducing a mammalian hyaluronidase gene into

Claims (20)

1. Жидкая композиция гиалуронидазы, содержащая1. A liquid hyaluronidase composition comprising гиалуронидазу, имеющую чистоту 95% или более и специфическую активность 70000 МЕ/мг или более, и стабилизатор гиалуронидазы, содержащий буферный агент для обеспечения рН от 4,0 до 6,0; от 0,001 до 0,5 об./об. % неионного поверхностно-активного вещества и от 0,1 до 5 мМ хелатообразующего агента или MgCl2.hyaluronidase having a purity of 95% or more and a specific activity of 70,000 IU / mg or more, and a hyaluronidase stabilizer containing a buffering agent to provide a pH of from 4.0 to 6.0; from 0.001 to 0.5 vol./about. % non-ionic surfactant and from 0.1 to 5 mm chelating agent or MgCl 2 . 2. Жидкая композиция гиалуронидазы по п. 1, представляющая собой инъецируемую композицию.2. The liquid hyaluronidase composition according to claim 1, which is an injectable composition. 3. Жидкая композиция гиалуронидазы по п. 1, обладающая стабильностью для поддержания активности гиалуронидазы вплоть до 90% или более по отношению к исходной ферментативной активности, принимаемой за 100, при температурных условиях от 2 до 8°C.3. The liquid hyaluronidase composition according to claim 1, which is stable for maintaining hyaluronidase activity up to 90% or more with respect to the initial enzymatic activity, taken as 100, under temperature conditions from 2 to 8 ° C. 4. Жидкая композиция гиалуронидазы по п. 1, где гиалуронидаза представляет собой активный компонент композиции.4. The liquid hyaluronidase composition according to claim 1, wherein the hyaluronidase is an active component of the composition. 5. Жидкая композиция гиалуронидазы по п. 4, где хелатообразующий агент представляет собой EDTA (этилендиаминтетрауксусная кислота).5. The liquid hyaluronidase composition according to claim 4, wherein the chelating agent is EDTA (ethylenediaminetetraacetic acid). 6. Жидкая композиция гиалуронидазы по п. 4, где неионное поверхностно-активное вещество выбрано из группы, состоящей из сложного эфира полиоксиэтиленсорбита и жирной кислоты и Triton Х-100.6. The liquid hyaluronidase composition according to claim 4, wherein the nonionic surfactant is selected from the group consisting of polyoxyethylene sorbitan fatty acid ester and Triton X-100. 7. Жидкая композиция гиалуронидазы по п. 6, где неионное поверхностно-активное вещество выбрано из группы, состоящей из полисорбата 20, полисорбата 80 и Triton Х-100.7. The liquid hyaluronidase composition of claim 6, wherein the nonionic surfactant is selected from the group consisting of polysorbate 20, polysorbate 80, and Triton X-100. 8. Жидкая композиция гиалуронидазы по п. 4, где буферный агент выбран из группы, состоящей из сукцинатного буфера, ацетатного буфера, фосфатного буфера, цитратного буфера, малонатного буфера, буфера на основе 2-(N-морфолино)этансульфоновой кислоты (MES), буфера Tris и глицинового буфера.8. The liquid hyaluronidase composition according to claim 4, wherein the buffering agent is selected from the group consisting of succinate buffer, acetate buffer, phosphate buffer, citrate buffer, malonate buffer, 2- (N-morpholino) ethanesulfonic acid (MES) buffer, Tris buffer and glycine buffer. 9. Жидкая композиция гиалуронидазы по п. 1, где гиалуронидаза представляет собой рекомбинантную гиалуронидазу, полученную путем трансдукции гена гиалуронидазы млекопитающих в микроорганизмы, клетки животных или клетки растений, или представляет собой экстракт, полученный из баранов, быков, свиней или людей.9. The liquid hyaluronidase composition according to claim 1, wherein the hyaluronidase is a recombinant hyaluronidase obtained by transducing a mammalian hyaluronidase gene into microorganisms, animal cells or plant cells, or is an extract obtained from rams, bulls, pigs or humans. 10. Жидкая композиция гиалуронидазы по п. 1, где гиалуронидаза очищена из содержащего гиалуронидазу материала посредством одного или более чем одного способа, выбранного из группы, состоящей из аффинной хроматографии, ионообменной хроматографии и гель-фильтрации.10. The liquid hyaluronidase composition according to claim 1, wherein the hyaluronidase is purified from a hyaluronidase-containing material by one or more methods selected from the group consisting of affinity chromatography, ion exchange chromatography and gel filtration. 11. Жидкая композиция гиалуронидазы по п. 10, где аффинная хроматография представляет собой аффинную хроматографию с использованием голубой сефарозы или аффинную хроматографию с использованием гепарин-сефарозы.11. The liquid hyaluronidase composition of claim 10, wherein affinity chromatography is affinity chromatography using blue sepharose or affinity chromatography using heparin sepharose. 12. Жидкая композиция гиалуронидазы по п. 10, где гиалуронидаза очищена посредством аффинной хроматографии с использованием голубой сефарозы, катионообменной хроматографии, анионообменной хроматографии и аффинной хроматографии с использованием гепарин сефарозы, следующих друг за другом.12. The liquid hyaluronidase composition of claim 10, wherein the hyaluronidase is purified by affinity chromatography using blue sepharose, cation exchange chromatography, anion exchange chromatography, and affinity chromatography using heparin sepharose, one after another. 13. Стабилизатор для жидкой композиции гиалуронидазы, содержащий буферный агент для обеспечения рН от 4,0 до 6,0; от 0,001 до 0,5 об./об. % неионного поверхностно-активного вещества и от 0,1 до 5 мМ хелатообразующего агента или MgCl2.13. A stabilizer for a liquid hyaluronidase composition containing a buffering agent to provide a pH of from 4.0 to 6.0; from 0.001 to 0.5 vol./about. % non-ionic surfactant and from 0.1 to 5 mm chelating agent or MgCl 2 . 14. Стабилизатор по п. 13, где хелатообразующий агент представляет собой EDTA.14. The stabilizer according to claim 13, wherein the chelating agent is EDTA. 15. Стабилизатор по п. 13, где неионное поверхностно-активное вещество выбрано из группы, состоящей из сложного эфира полиоксиэтиленсорбита и жирной кислоты и Triton Х-100.15. The stabilizer according to claim 13, wherein the nonionic surfactant is selected from the group consisting of polyoxyethylene sorbitan fatty acid ester and Triton X-100. 16. Стабилизатор по п. 13, где буферный агент выбран из группы, состоящей из сукцинатного буфера, ацетатного буфера, фосфатного буфера, цитратного буфера, малонатного буфера, буфера MES (2-(N-морфолино)этансульфоновой кислоты), буфера Tris и глицинового буфера.16. The stabilizer according to claim 13, where the buffer agent is selected from the group consisting of succinate buffer, acetate buffer, phosphate buffer, citrate buffer, malonate buffer, MES buffer (2- (N-morpholino) ethanesulfonic acid), Tris buffer and glycine buffers. 17. Стабилизатор по п. 13, где гиалуронидаза очищена из содержащего гиалуронидазу материала посредством одного или более чем одного способа, выбранного из группы, состоящей из аффинной хроматографии, ионообменной хроматографии и гель-фильтрации.17. The stabilizer according to claim 13, wherein the hyaluronidase is purified from the hyaluronidase-containing material by one or more methods selected from the group consisting of affinity chromatography, ion exchange chromatography, and gel filtration. 18. Стабилизатор по п. 17, где аффинная хроматография представляет собой аффинную хроматографию с использованием голубой сефарозы или аффинную хроматографию с использованием гепарин-сефарозы.18. The stabilizer according to claim 17, where affinity chromatography is an affinity chromatography using blue sepharose or affinity chromatography using heparin sepharose. 19. Стабилизатор по п. 18, где гиалуронидаза очищена посредством аффинной хроматографии с использованием голубой сефарозы, катионообменной хроматографии, анионообменной хроматографии, аффинной хроматографии с использованием гепарин-сефарозы и гель-фильтрации, следующих друг за другом.19. The stabilizer according to claim 18, where the hyaluronidase is purified by affinity chromatography using blue sepharose, cation exchange chromatography, anion exchange chromatography, affinity chromatography using heparin sepharose and gel filtration, following each other. 20. Стабилизатор по п. 13, где гиалуронидаза представляет собой рекомбинантную гиалуронидазу, полученную путем трансдукции гена гиалуронидазы млекопитающих в микроорганизмы, клетки животных или клетки растений, или представляет собой экстракт, полученный из баранов, быков, свиней или людей. 20. The stabilizer according to claim 13, wherein the hyaluronidase is a recombinant hyaluronidase obtained by transducing a mammalian hyaluronidase gene into microorganisms, animal cells or plant cells, or is an extract obtained from rams, bulls, pigs or humans.
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